Device for collection, storage, retrieval and shipping of hair follicles from animals

ABSTRACT

The present invention relates to a novel device for the collection, storage, shipping and retrieval of hair follicles from animals for the purpose of isolating DNA or other genetic material from the follicles for analysis. The device has outer flaps for the protection as well as identification of the samples and an inner part where samples are placed. The inner device has thicker base and a clear plastic cover, the easy peel back of which is facilitated by a) low tack adhesives that hold the two together and b) a touch cut on one end, through the base sheet which creates a grip. This makes the device convenient and easy to use, and yet a robust collection device for hair follicles from animals in a farm or real-life situation. Hair follicles can be punched out through the inner device for direct DNA isolation and analysis.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims the benefit of andpriority to U.S. Non-provisional patent application Ser. No. 12/054,839,filed Mar. 25, 2008, now U.S. Pat. No. 7,959,000, which application is acontinuation of and claims the benefit of and priority to U.S.Non-provisional patent application Ser. No. 10/857,669, filed May 29,2004, now U.S. Pat. No. 7,470,399, which documents are herebyincorporated by reference in their entireties to the extent permitted bylaw.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

Not applicable.

BACKGROUND OF THE INVENTION

The rapid growth and development in the area of molecular biology hasallowed the development of numerous genetic tests for animals. As thenumber of useful tests increase, there will be an increase in the numberof samples to be tested. Currently, the number of samples that are beingsent for DNA analysis are increasing exponentially. Also, the types ofsamples that are sent for DNA analysis can vary from place to place andorganization to organization. In other words, for animals, the sourcematerial for DNA can be hair follicles, ear notches or ear punches,blood and meat samples (if the animal is already dead). In all cases,the type of samples will be determined by the individual or theorganization collecting the samples. Some ranches that specialize inbeef cattle may find it easy to get ear notches when the animals arerounded up for selling or some ranches may find it convenient to collecthair from tail switches when a new calf is born. Whatever the case maybe, there is no single, easy to use device that is convenient for fielduse as well as for laboratory use. A unique and novel device has to workequally well in the field where the sample is collected and has to workequally well in a laboratory where the biological sample is to beisolated and subject to numerous biochemical tests.

No single device or system exists that allow the easy collection, safestorage and shipping as well as the ability to isolate DNA; all combinedin one device. In recent years, several approaches have been made tocreate sample collection kits for human hair (Bierke-Nelson et al, 1999,Elliot et al, 2003). None of the devices or systems used todayspecifically approaches the issues regarding a) ease of collection ofsamples, b) ease of identification of samples and c) ability to keepsamples for long time and d) ability to isolate DNA through the deviceso as to get routine amplification of DNA possible. One has to considerthe fact that most animal samples are collected in the field and hencethe collection device should be sturdy as well as easy to use andwithout any disposable or removable part or component.

BRIEF DESCRIPTION OF INVENTION

The present invention relates to a novel device for the collection,storage, shipping and retrieval of hair follicles from animals for thepurpose of isolating DNA or other genetic material from the folliclesfor analysis. The device has outer flaps for the protection as well asidentification of the samples and an inner part where samples are placedon low tack adhesives. The low tack adhesive component allows peeling ofa clear plastic cover which allows visibility of the sample once placedinside and the easy peeling of the plastic cover is facilitated by atouch cut that is one of the uniqueness of this device. The ease ofpeeling the clear sheet along with the ability to hold the entire devicewith the outer flaps makes it a convenient and easy to use, yet robustcollection device for hair follicles from animals in a farm or real-lifesituation.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

There are 3 figures labeled FIG. 1, FIG. 2 and FIG. 3. None of thefigures are drawn to scale. The figures are for the purpose of showingdetails of the device and its functionality.

FIG. 1. Lateral view of the device. The closed device is shown with theexternal cover flap as viewed from the top. The arrow indicated as (3)shows the tab that is on the top outer flap inserted into the bottomouter flap through a slit on the bottom flap. The arrow indicated as (1)shows the fold crease that allows the outer flaps to be folded. Theouter flap also has areas to write useful information about the samplelike Name, Animal ID, Signature of submitting person, date etc. The backof the device (back of bottom flap) typically has a unique barcode thatis used to identify each device.

FIG. 2. Open view of device showing outer flaps and inner device. Theopen device shows outer flaps (2) and (5) that are open exposing theinner device (11) which is attached to the outer flaps (2), (5) withglue in the general area that is marked with arrow (10) (e.g., to secureentire device as one unit. The folded crease (1) is found on the top (2)and bottom (5) outer flaps and allows opening of the protective outerflaps (2), (5). The inner device (11) has a lower base sheet which isindicated by arrow marked (7). The lower base sheet (7) is slightlythicker than the upper clear plastic which is indicated by arrow marked(8). The two sheets (7), (8) are layered on each other using low tackadhesives, the concept of which is indicated by arrow marked (9). Thelower base sheet (7) of the inner device (11) is cut using a touch cutdevice and this cut stops at the upper clear plastic sheet (8). The cutis indicated by arrow marked (6). The cut completely cuts the lower basesheet (7) but does not cut the upper clear plastic sheet (8). Thisallows the use of the cut area in which part of the lower base sheet (7)is attached to the clear plastic sheet (8) as a grip (12) to peel theclear plastic sheet (8) back. Since low tack glue is used, the plasticsheet (8) can be peeled back and re-attached at will. To close deviceafter putting a sample in the inner device (11), the whole unit ispressed together by hand and tab (3) is inserted to slit (4) which willhold all contents securely.

FIG. 3. Open inner device. This figure shows open flaps using thefolding crease as indicated by arrow marked (1). The inner device (11)is shown, with the clear plastic that is indicated by arrow marked (8),being peeled back from the lower base sheet (7). This exposes the lowtack adhesive as indicated by arrow marked (9). Hair follicles can beplaced in between the clear plastic sheet (8) and the lower base sheet(7) and secured by placing the clear plastic sheet (8) back on top ofthe sample and then closing the entire device. The touch cut (6) createsa grip (12) on the upper clear plastic sheet (8) by leaving a part ofthe lower base sheet (7) as indicated by arrow marked (12). The touchcut (6) is now exposed as the edge of the lower base sheet (7) and thisis indicated by arrow marked (13).

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a unique device for collecting biologicalsamples from animals and allowing proper identification, long-termstorage, shipping as well as the ability to easily isolate geneticmaterial from the biological sample.

The basic design is described in FIG. 1. The details of the device isderived from FIG. 2 and the use of the device can be inferred from FIG.3. The entire device is about the size of a standard business card. Thesize can be varied to any requirement. There are two paper flaps thatcan be opened by a fold created in the paper and also by attaching thepaper using glue or any other adhesive. The device has a folding creaseclose to the main fold that allows the user to hold the device in onehand which allows easy separation of the paper flaps with the other. Thetwo paper flaps are outer covers that protect the biological sample thatis to be placed within a specialized part that is within the two flaps.The two outer flaps are used also to identify the source of the materialand has adequate room for basic sample information like name of theanimal, animal ID, date and signature of submitting individual. On theoutside or inside of the outer flaps is sufficient space forinstruction. In most cases, the outside of the lower flap is used toprint a unique barcode that identifies each device. The outer paper canbe card stock or similar paper so that the device is sturdy and can beused in the field. In the present embodiment, the inside device(protected by the two outer flaps) is a clear plastic sheet that isplaced on a paper or plastic base that is white or any other color thatallows easy recognition of hair follicles, once the hair follicles areinside the device. The paper or plastic base is made of slightly heaviermaterial than the outer clear plastic so that it can act as a base. Theinner device is attached to the outer device using adhesives placedclose to the folded area of the outer cover. This is indicated in FIG. 2and marked by arrow (10). The clear plastic top allows easyvisualization of hair follicles once it is placed in the device by theperson collecting the samples, as well as personnel in a laboratory whomight be using the follicles to isolate DNA. The clear plastic top sheetis layered on the base sheet using low tack adhesive that allows easypeeling back of the clear plastic sheet as well as easy re-closing. Sucha paper combination with low tack adhesives can be found as off theshelf product from graphic film suppliers. A touch cut on the edge ofthe base sheet (edge away from the attached area) allows for easy peelback of the clear plastic sheet due to the low tack adhesive. A touchcut is a machine derived cut that slices to set depth and in this case,cuts deep enough so as to cut the base sheet only and not the clearplastic. The clear plastic sheet cannot be completely peeled off thebase sheet since the entire inner device is attached to the outer coverthus allowing for an environmentally friendly device which does not haveany removable component.

Using the Device

The present embodiment is primarily used to place hair folliclescollected from any animal species that has visible follicles. To placehair follicles, the two outer flaps are opened initially to expose theinner part. The touch cut on the base sheet on the inside part allowsthe outer plastic to be slowly peeled towards the crease of the outercover thus exposing the low tack adhesive. The clear plastic sheet iseasily pulled back due to the touch cut and the thicker lower base sheet(that is now stuck on the peeled plastic) acts as a good grip on theouter clear plastic. See FIG. 3 for a clear picture of this. It showsthe inner device where the outer plastic is being peeled from the basesheet and this is done very easily due to the low tack adhesive thatholds the clear plastic on the lower base. This is again useful forfield uses as most samples from animals are collected in the field. Hairsamples with follicles are placed within the peeled off area with thefollicles all clumped together and this can be in any direction that isconvenient to the user. The peeled back clear plastic is placed back onthe hair samples, pressed firmly down with fingers and the two outerflaps are closed by inserting the tab into the lower outer flap slit.Any excess hair is trimmed off if necessary. Relevant information aboutthe sample can be indicated on the outer flaps along with the animal ID.The presence of a collection device ID (the barcode or any other numberor ID system present on the device) allows linking of the sample to itscollection device ID (for example barcode of the collection device) andvice-versa. Once in the device, the sample can be stored at roomtemperature for an indefinite period of time and allows the easyshipment of samples in a regular or padded envelope.

Isolation of DNA from Hair Follicles that are in the Collection Device

For isolating DNA or other nucleic acid from the hair follicles, thefollicles can be removed one at a time or in groups if necessary so thateach follicle can be cut out with a sharp device like scissors. Thedevice is designed in such a way that allows for the laboratorytechnician to visibly inspect the hair follicles and determine whichfollicle to remove. Individual follicles can be removed by simplypeeling the outer plastic cover using the touch cut grip. This ispossible due to the low tack adhesive that is used in the device.Removal of the follicle can be accomplished by punching out the hairfollicle from the internal part of the device that holds the hair, usinga punching device (1.2 mm Harris Micro punch (Whatman Biosciences) orsimilar device). The follicles can be punched out through the outerclear plastic and the lower base. All the follicles can be punched outfrom a device or just the sufficient number to isolate DNA. Typically, 1to 5 follicles are sufficient to generate enough genomic DNA so as tofacilitate DNA analysis using amplification methods like PCR (polymerasechain reaction (Erlich, H. A. 1989.)). The clear plastic sheet or thebase sheet as well as the adhesive can be selected so as to selectmaterials that do not inhibit reactions like the polymerase chainreaction that is routinely used in several labs to allow amplificationof DNA for further analysis.

What is claimed is:
 1. A collection device for collecting hair sampleswith a follicle, the device comprising: (a) a top flap; (b) a bottomflap coupled to the top flap at a seam; and (c) an inner device disposedbetween the top flap and the bottom flap and coupled to both of the topflap and the bottom flap only at a region proximate to the seam, the topflap and the bottom flap each having a fold line proximate the seam toallow both flaps to be opened to expose the inner device, the innerdevice comprising a base and a top sheet, the top sheet being fixedlycoupled to the base at a first region of the top sheet proximate to theseam and the top sheet being partially separably coupled to the base ata second region of the top sheet comprising substantially all of an areaof overlap of the base by the top sheet and extending away from the seamand the first region, the first region and the second region beingintegral and non-separable; and wherein the base comprises a gripfixedly coupled to an end of the top sheet that is distal to the seamand the first region of the top sheet and that is defined by a touch cutthat extends through the base and not through the top sheet.
 2. Thecollection device of claim 1, wherein the top sheet comprises a clearplastic.
 3. The collection device of claim 2, wherein the base comprisesa plastic that is more rigid than the clear plastic of the top sheet. 4.The collection device of claim 1, wherein the base comprises paper. 5.The collection device of claim 1, wherein the hair sample is an animalhair sample.
 6. The collection device of claim 1, wherein the innerdevice is coupled to both of the top flap and the bottom flap by anadhesive.
 7. The collection device of claim 1, wherein an outer surfaceof one or both of the top flap and bottom flap comprises a uniqueidentifier for the collection device.
 8. The collection device of claim7, wherein the unique identifier comprises a machine readable barcode.9. The collection device of claim 1, further comprising a hair folliclesample fixed by an adhesive in the inner device between and in contactwith both the base and the top sheet of the inner device.
 10. Thecollection device of claim 1, wherein the top sheet cannot be completelyremoved from the base sheet.
 11. The collection device of claim 1,wherein the collection device comprises only a single inner devicebetween the top flap and the bottom flap.
 12. The collection device ofclaim 1, wherein the grip is defined by a part of the base that is touchcut from a main part of the base.
 13. A collection device for collectingbiological samples, the device comprising: (a) a first flap having atab; (b) a second flap coupled to the first flap at a seam and having,at an end opposite at an end opposite of the seam, a slit for receivingthe tab to facilitate closure of the collection device: (c) an innerdevice disposed between the top first flap and the bottom second flapand coupled to both the first flap and second flap only at a regionproximate to the seam, the first flap and second flap each having a foldline proximate the seam to allow both flaps to be opened to expose theinner device, the inner device comprising a base and a top sheet, thetop sheet being fixedly coupled to the base at a first region of the topsheet proximate to the seam and the top sheet being partially separablycoupled to the base at a second region of the top sheet comprisingsubstantially all of an area of overlap of the base by the top sheet andextending away from the seam and the first region, the first region andsecond region being integral and non-separable; wherein an outer surfaceof one or both of the first flap and second flap comprises a uniqueidentifier for the collection device; and wherein the base comprises agrip fixedly coupled to an end of the top sheet that is distal to theseam and the first region of the top sheet and that is defined by atouch cut that extends through the base and not through the top sheet.14. The collection device of claim 13, wherein the top sheet comprises aclear plastic.
 15. The collection device of claim 13, wherein the basecomprises paper.
 16. The collection device of claim 13, wherein theinner device is coupled to both the first flap and second flap by anadhesive.
 17. The collection device of claim 13, wherein the uniqueidentifier comprises a machine readable barcode.
 18. The collectiondevice of claim 13, further comprising a hair follicle sample fixed byan adhesive in the inner device between and in contact with both thebase and the top sheet of the inner device.
 19. The collection device ofclaim 13, wherein: the top sheet cannot be completely removed from thebase sheet.
 20. The collection device of claim 13, wherein thecollection device comprises only a single inner device between the firstflap and the second flap.
 21. A biological sample collection kitcomprising: (a) a plurality of collection devices according to claim 13;wherein each collection device in the kit has a unique identifier toidentify each collection device.
 22. A collection device for collectinghair samples with a follicle, the device comprising: (a) a top flap; (b)a bottom flap coupled to the top flap at a first location; and (c) aninner device disposed between the top flap and the bottom flap andcoupled to both of the top flap and the bottom flap only at a regionproximate to the first location, the inner device comprising a base anda top sheet, the top sheet being fixedly coupled to the base at a firstregion of the top sheet proximate to the first location and the topsheet being partially separably coupled to the base at a second regionof the top sheet comprising substantially all of an area of overlap ofthe base by the top sheet and extending away from the first location andthe first region, the first region and the second region being integraland non-separable; and wherein the base comprises a grip fixedly coupledto an end of the top sheet that is distal to the first location and thefirst region of the top sheet and that is defined by a touch cut at asecond location that extends through the base and not through the topsheet.